Senior Quality Engineer

STERIS; Guadalupe; Presencial; USD 30,000 - 50,000; Jornada completa

Descripción de la vacante

A leading global provider in healthcare and life sciences is seeking a Quality Engineer to enhance quality systems and ensure compliance with various standards. The ideal candidate will have a Bachelor's degree in Engineering and significant experience in Manufacturing/Quality Engineering, focusing on continuous improvement and statistical analysis. This role offers an opportunity to impact product quality and safety in a dynamic environment.

Formación

• 5-7 years in Manufacturing/Quality Engineering and/or Quality Systems.
• Experience with medical devices or regulated industries preferred.
• Familiarity with QSR/GMP regulations and certifications like ASQ preferred.

Responsabilidades

• Maintain and improve the quality system according to ISO standards.
• Participate in cross-functional new product development teams.
• Develop and implement statistically valid sampling plans.

Conocimientos

Bilingual

Problem-solving

Continuous improvement

Organizational skills

Communication skills

Documentation skills

Educación

Bachelor's Degree in Engineering

Herramientas

Statistical analysis software

PC applications (Excel, Word, PowerPoint)

Descripción del empleo

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

The Quality Engineer is responsible for maintaining and improving the quality system in accordance with standards such as ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable standards. This role supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement using statistical techniques and other accepted quality principles. The role involves activities related to the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

Duties

1. Participate in cross-functional new product development teams focusing on product/service quality and Quality System compliance.
2. Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC, and trend analysis.
3. Initiate and/or participate in process and product corrective actions and problem-solving activities.
4. Update and establish documented work instructions as needed.
5. Review data to perform statistical analysis and recommend process/product changes to improve quality.
6. Monitor and report on performance metrics such as warranties, OOB, Installation and Manufacturing DPU, FPY analysis, and lead the development of action plans to improve KPIs.
7. Instruct other employees in quality principles, effective corrective actions, and statistical techniques.
8. Collaborate with other departments and facilities on quality issues.
9. Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
10. Perform quality system audits and guide corrective actions.
11. Handle customer complaints.
12. The Welding Quality Engineer is responsible for nondestructive testing (NDT) per CSEI (AQSIQ). Additional responsibilities include:
13. ASME and PED Code Activities
14. Understanding of ASME / PED / International Standards for pressure vessels
15. Participate in safety, continuous improvement, and training initiatives, including A3 Certification, STOP observations, safety audits, KPI management, CIP projects, and system upgrades.
16. Maintain and improve the quality system according to standards such as ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, NOM-241-SSA1, and others.

Education Degree

• Bachelor's Degree in Engineering (General)

Required Experience

• 5-7 years in Manufacturing/Quality Engineering and/or Quality Systems.
• Experience with medical devices or regulated industries preferred.
• Experience in an ISO certified environment required.
• Familiarity with QSR/GMP regulations and certifications like ASQ or QSR preferred.

Skills

• Bilingual (90%)
• Excellent problem-solving skills
• Focus on issue identification and continuous improvement
• Experience in cross-functional teams and independent work
• Strong organizational, communication, and documentation skills
• Proficiency in PC applications including Excel, Word, PowerPoint
• Experience with statistical analysis software and Visio preferred

STERIS is a leading global provider of products and services supporting patient care, emphasizing infection prevention. We help our customers create a healthier and safer world through innovative healthcare, life sciences, and dental products and services. As a $5 billion, NYSE-listed company with approximately 17,000 employees and customers in over 100 countries, STERIS is committed to diversity and equal opportunity employment.